Cannabidiol in Treatment of Pain due to Attrition of the Knee Joint

Phase 1

• Conditions: Painful osteoarthritis of the knee; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: EUCTR2019-003591-40-AT
• Lead Sponsor: Medizinische Universität Wien, Universitätsklinik für Anästhesie, Allgemeine Intensivmedizin und Schmerztherapie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-03-24
• Last Update Posted: 22 June 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 86

Inclusion Criteria

• Patient must be willing and able to give informed consent for
participation in the study
• Age 18-80 years
• Knee Pain
WOMAC Pain Subscale = 5 during screening
• Mean Visual Analogue Scale (VAS) = 5 during 1 week of screening.
• Fulfilment of the clinical criteria of the American College of
Rheumatology for knee OA 8
• X-ray or MRI confirmation of knee osteoarthritis within the previous
12 months
• All medications or interventions for pain due to knee osteoarthritis
must have been stable for two weeks prior to screening and patient is
willing to maintain a
stable regimen throughout the study.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 66
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

• Current mood disorder (dysthymia, bipolar mood disorder)
• Major Depression > 12 months (Beck Depression Inventory Score =
18)
• History of a psychoactive substance use disorder within the preceding
12 months
• Major coexisting medical illness (e.g. severe heart failure, pulmonary
hypertension, renal insufficiency)
• Glaucoma
• Acute myocardial infarction
• Uncontrolled hypertension
• History of convulsion
• Pregnancy; women of childbearing age will be required to use
contraceptives during the duration of the study. Furthermore a
pregnancy test will be performed prior to the beginning of the study and
once a month during the study period.
• Breast feeding
• Participation in a clinical trial in the 3 weeks preceding the study
• Allergy to study medication
• Recent intra-articular corticosteroid or hyaluronic acid injection in the
knee joint. Patients must be willing to abstain from such interventions
during the entire study
• Use of the following medication:
- opioids except for tramadol,
- benzodiazepines other than indicated at low doses for sleep disorders
- NSAID
• Impaired kidney function (Creatinine > 1.5mg/dl)
• Patient has significantly impaired hepatic function
defined as any of the following:
- Alanine aminotransferase (ALT) or aspartate aminotransferase
(AST) >5 × upper limit of normal (ULN).
- ALT or AST >3 × ULN and (total bilirubin [TBL] >2 × ULN
or international normalized ratio [INR] >1.5).
- ALT or AST >3 × ULN with the presence of fatigue, nausea, vomiting,
right upper quadrant pain or tenderness, fever, rash,and/or eosinophilia
(>5%).
• Patient is currently using or has in the past used recreational or
medicinal cannabis or synthetic cannabinoid based medications within 3
months prior to study entry
• Patient is unwilling to abstain from using recreational or medicinal
cannabis, or synthetic cannabinoid based medications during the study
• Patients who are not able to understand the study measures and are
not able to complete pain assessment forms.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified